BEUDAMED
    FDA Adverse Event Other Summary report: N

    SHEATH

    MDR report key: 17278653 · Received July 6, 2023

    Report

    Report Number
    MW5119162
    Event Type
    Other
    Date Received
    July 6, 2023
    Date of Event
    June 2, 2023
    Report Date
    July 2, 2023
    Manufacturer
    COOK INCORPORATED
    Product Code
    DYB
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    DURING CARDIOMEMS IMPLANT PROCEDURE THE PHYSICIAN LOST GUIDEWIRE PLACEMENT DUE TO DIFFICULTY WITH PATIENT ANATOMY. THE PHYSICIAN DECIDED TO RETRACT THE WIRE AND DELIVERY SYSTEM OUT OF THE BODY HOWEVER WHILE ATTEMPTING TO RETRACT THE SENSOR THROUGH THE (COOK) SHEATH IT BECAME DAMAGED. THE DELIVERY CATHETER WAS CUT AND THE SENSOR WAS SAFELY REMOVED. THE IMPLANT WAS SUCCESSFULLY COMPLETED USING A NEW SENSOR. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613372 SHEATH INTRODUCER, CATHETER DYB COOK INCORPORATED

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown